A randomized trial of progesterone in women with bleeding in early pregnancy

Coomarasamy, A. et al. (2019) A randomized trial of progesterone in women with bleeding in early pregnancy. New England Journal of Medicine, 380(19), pp. 1815-1824. (doi: 10.1056/NEJMoa1813730) (PMID:31067371)

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Background: Bleeding in early pregnancy is strongly associated with pregnancy loss. Progesterone is essential for the maintenance of pregnancy. Several small trials have suggested that progesterone therapy may improve pregnancy outcomes in women who have bleeding in early pregnancy. Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate progesterone, as compared with placebo, in women with vaginal bleeding in early pregnancy. Women were randomly assigned to receive vaginal suppositories containing either 400 mg of progesterone or matching placebo twice daily, from the time at which they presented with bleeding through 16 weeks of gestation. The primary outcome was the birth of a live-born baby after at least 34 weeks of gestation. The primary analysis was performed in all participants for whom data on the primary outcome were available. A sensitivity analysis of the primary outcome that included all the participants was performed with the use of multiple imputation to account for missing data. Results: A total of 4153 women, recruited at 48 hospitals in the United Kingdom, were randomly assigned to receive progesterone (2079 women) or placebo (2074 women). The percentage of women with available data for the primary outcome was 97% (4038 of 4153 women). The incidence of live births after at least 34 weeks of gestation was 75% (1513 of 2025 women) in the progesterone group and 72% (1459 of 2013 women) in the placebo group (relative rate, 1.03; 95% confidence interval [CI], 1.00 to 1.07; P=0.08). The sensitivity analysis, in which missing primary outcome data were imputed, resulted in a similar finding (relative rate, 1.03; 95% CI, 1.00 to 1.07; P=0.08). The incidence of adverse events did not differ significantly between the groups. Conclusions: Among women with bleeding in early pregnancy, progesterone therapy administered during the first trimester did not result in a significantly higher incidence of live births than placebo. (Funded by the United Kingdom National Institute for Health Research Health Technology Assessment program; PRISM Current Controlled Trials number, ISRCTN14163439.).

Item Type:Articles
Additional Information:Supported by the United Kingdom NIHR Health Technology Assessment program (project number HTA 12/167/26).
Glasgow Author(s) Enlighten ID:Norman, Professor Jane and Lumsden, Professor Mary
Authors: Coomarasamy, A., Devall, A. J., Cheed, V., Harb, H., Middleton, L. J., Gallos, I. D., Williams, H., Eapen, A. K., Roberts, T., Ogwulu, C. C., Goranitis, I., Daniels, J. P., Ahmed, A., Bender-Atik, R., Bhatia, K., Bottomley, C., Brewin, J., Choudhary, M., Crosfill, F., Deb, S., Duncan, W. C., Ewer, A., Hinshaw, K., Holland, T., Izzat, F., Johns, J., Kriedt, K., Lumsden, M.-A., Manda, P., Norman, J. E., Nunes, N., Overton, C. E., Quenby, S., Rao, S., Ross, J., Shahid, A., Underwood, M., Vaithilingam, N., Watkins, L., Wykes, C., Horne, A., and Jurkovic, D.
College/School:College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:New England Journal of Medicine
Publisher:Massachusetts Medical Society
ISSN (Online):1533-4406
Copyright Holders:Copyright © 2019 Massachusetts Medical Society
First Published:First published in New England Journal of Medicine 380(19):1815-1824
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher

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